Outlook Therapeutics Says UK MHRA Grants Marketing Authorization For LYTENAVA To Treat Wet AMD

RTTNews | 395 dni temu
Outlook Therapeutics Says UK MHRA Grants Marketing Authorization For LYTENAVA To Treat Wet AMD

(RTTNews) - Biopharmaceutical company Outlook Therapeutics, Inc. (OTLK) announced Monday that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA (bevacizumab gamma).

LYTENAVA is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK.

This approval comes after Outlook Therapeutics was recently granted Marketing Authorization for LYTENAVA by the European Commission for the same therapeutic indication.

The Marketing Authorization Application (MAA) submission to the MHRA was completed under the new International Recognition Procedure (IRP), which allows the MHRA to rely on a positive opinion by the European Medicines Agency's CHMP concerning an application for granting marketing authorization for the same product in the EU in the MHRA's authorization decision.

As part of a multi-year planning process, Outlook Therapeutics entered a strategic collaboration with Cencora (COR) (formerly AmerisourceBergen) to support the commercial launch of LYTENAVA globally following regulatory approvals.

Cencora will provide comprehensive launch support in the EU and the UK including pharmacovigilance, regulatory affairs, quality management, market access support, importation, third-party logistics (3PL), distribution and field solutions.

The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA to benefit all stakeholders, including retina specialists, providers and patients.

read more
U.S. Wholesale Inventories Inch Up Less Than Expected In June

U.S. Wholesale Inventories Inch Up Less Than Expected In June

Wholesale inventories in the U.S. crept up by less than expected in the month of June, according to a report released by the Commerce Department on Thursday. The Commerce Department said wholesale inventories inched up by 0.1 percent in June after falling by 0.3 percent in May. Economists had expected wholesale inventories to rise by 0.2 percent, in line with the preliminary estimate.
RTTNews | 53 minut temu
U.S. Labor Productivity Rebounds Roughly In Line With Estimates In Q2

U.S. Labor Productivity Rebounds Roughly In Line With Estimates In Q2

Labor productivity in the U.S. saw a significant rebound in the second quarter of 2025, according to preliminary data released by the Labor Department on Thursday. The report said labor productivity shot up by 2.4 percent in the second quarter after tumbling by a downwardly revised 1.8 percent in the first quarter.
RTTNews | 1g 24 minut temu
U.S. Jobless Claims Rise More Than Expected To 226,000

U.S. Jobless Claims Rise More Than Expected To 226,000

A report released by the Labor Department on Thursday showed first-time claims for U.S. unemployment benefits rose by more than expected in the week ended August 2nd. The Labor Department said initial jobless claims climbed to 226,000, an increase of 7,000 from the previous week's revised level of 219,000.
RTTNews | 1g 35 minut temu
Bank Of England Cuts Rate In Tight Vote

Bank Of England Cuts Rate In Tight Vote

The Bank of England reduced its benchmark interest rate in a close call on Thursday suggesting that the monetary easing cycle is nearing an end as policymakers became more concerned about persistent inflation. The Monetary Policy Committee, headed by BoE Governor Andrew Bailey, voted 5-4 to cut the bank rate by 25 basis points to 4.00 percent.
RTTNews | 2g 32 minut temu